COLDCURVE LIMITED

Quality Management System Manual

Revision A Issued May-17

Conforms to ISO 9001:2015

(c) 2017 Coldcurve Limited; all rights reserved. This document may contain proprietary information and may only be released to third

parties with approval of management. Document is uncontrolled unless otherwise marked; uncontrolled documents are not subject to update notification.

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TABLE OF CONTENTS

0.0 Revision History and Approval ................................................................................................................................. 3 1.0 Welcome to Coldcurve Limited ................................................................................................................................ 4 2.0 About The Coldcurve Ltd Quality Manual ................................................................................................................. 4 3.0 Terms and Definitions .............................................................................................................................................. 4 4.0 The Scope and Context of the Coldcurve Ltd QMS ................................................................................................... 5

4.1 Determining Our Strategic Direction .................................................................................................................... 5 4.2 Scope of the Management System ...................................................................................................................... 5

4.2.1 Scope Statement ......................................................................................................................................... 5 4.2.2 Facilities Within the Scope .......................................................................................................................... 6 4.2.3 Permissible Exclusions ................................................................................................................................. 6 4.2.4 Scope of the Quality Management System Manual ..................................................................................... 6

5.0 Quality Policy ........................................................................................................................................................... 6 6.0 Management System Processes ............................................................................................................................... 7

6.1 Process Identification .......................................................................................................................................... 7 6.2 Process Controls & Objectives ............................................................................................................................. 7 6.3 Outsourced Processes ......................................................................................................................................... 8

7.0 Documentation & Records ....................................................................................................................................... 8 7.1 General ................................................................................................................................................................ 8 7.2 Control of Documents.......................................................................................................................................... 9 7.3 Control of Records ............................................................................................................................................... 9

8.0 Management & Leadership ...................................................................................................................................... 9 8.1 Management Leadership and Commitment ......................................................................................................... 9 8.2 Customer Focus ................................................................................................................................................. 10 8.3 Quality Policy ..................................................................................................................................................... 10 8.4 Organizational Roles Responsibilities & Authorities ........................................................................................... 10 8.5 Internal Communication .................................................................................................................................... 11 8.6 Change Management ........................................................................................................................................ 11 8.7 Risks and Opportunities ..................................................................................................................................... 11 8.8 Management Review ......................................................................................................................................... 12

9.0 Resources .............................................................................................................................................................. 12 9.1 Provision of Resources ....................................................................................................................................... 12 9.2 Human Resources .............................................................................................................................................. 12 9.3 Infrastructure .................................................................................................................................................... 12 9.4 Work Environment ............................................................................................................................................ 13 9.5 Organizational Knowledge ................................................................................................................................. 13

10.0 Operation .............................................................................................................................................................. 14 10.1 Operational Planning and Control ...................................................................................................................... 14 10.2 Customer-Related Activities .............................................................................................................................. 14 10.3 Customer Communication ................................................................................................................................. 14 10.4 Design and Development ................................................................................................................................... 15 10.5 Purchasing ......................................................................................................................................................... 15 10.6 Provision of products and services ..................................................................................................................... 15

10.6.1 Control of Provision of products and services ............................................................................................ 15 10.6.2 Identification and Traceability ................................................................................................................... 16 10.6.3 Property Belonging to Third Parties ........................................................................................................... 16 10.6.4 Preservation .............................................................................................................................................. 16 10.6.5 Post-Delivery Activities .............................................................................................................................. 16 10.6.6 Process Change Control............................................................................................................................. 17 10.6.7 Measurement and Release of products and services ................................................................................. 17 10.6.8 Control of Nonconforming Outputs ........................................................................................................... 17

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11.0 Improvement ......................................................................................................................................................... 17 11.1 General .............................................................................................................................................................. 17 11.2 Customer Satisfaction ........................................................................................................................................ 18 11.3 Internal Audit .................................................................................................................................................... 18 11.4 Corrective and Preventive Action....................................................................................................................... 18

Appendix A: Overall Process Sequence & Interaction .................................................................................................... 19 Appendix B: ISO 9001:2015 Cross Reference ................................................................................................................. 20

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0.0 Revision History and Approval

Rev. Nature of changes Approval Date

A Original release. J. Reid May-17

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1.0 Welcome to Coldcurve Limited

Coldcurve Ltd is a multi-disciplined engineering solutions provider in custom PC, PLC, HMI, SCADA and electrical system design, creation and installation. Our specialist team tailors to your individual company requirements, creating bespoke solutions to improve the quality and efficiency of your company's output. We offer complete electrical design, construction, installation and maintenance. By using the best components for your application and budget, Coldcurve Ltd creates automation and electrical control packages tailored to the client's specifications.

2.0 About The Coldcurve Ltd Quality Manual

This manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard. This manual is not aligned with the clause numbering scheme of ISO 9001; instead, Appendix B provides a cross-reference table that shows where, in the manual, each ISO 9001 requirement is addressed. This manual presents “Notes” which are used to define how Coldcurve Ltd has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015.

Notes appear in italics, with gray background. Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics.

3.0 Terms and Definitions

Coldcurve Ltd adopts the following terms and definitions within its Quality Management System. Where no definition is provided, the company typically adopts the definitions provided in ISO 9000: Quality Management – Fundamentals and Vocabulary. In some cases, specific procedures or documentation may provide a different definition to be used in the context of that document; in such cases, the definition will supersede those provided for in this Quality Manual or ISO 9000. General Terminology

Coldcurve Ltd – Coldcurve Limited Document – written information used to describe how an activity is done. Record – captured evidence of an activity having been done.

Risk-Based Thinking Terminology Risk – Negative effect of uncertainty Opportunity – Positive effect of uncertainty Uncertainty - A deficiency of information related to understanding or knowledge of an event, its consequence, or likelihood. (Not to be confused with measurement uncertainty.)

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Nonconforming Product Terminology

Rework: Efforts to bring nonconforming product into conformance through additional operations that do not alter the original design of the product. Repair: Efforts to bring nonconforming product into conformance through additional operations that alter the original design of the product; this may be through the addition of material no specified in the original design, or through altering pre-existing design features. Scrap: The discard of nonconforming product in lieu of rework or repair.

4.0 The Scope and Context of the Coldcurve Ltd QMS

4.1 Determining Our Strategic Direction

Coldcurve Ltd has reviewed and analyzed key aspects of itself and its stakeholders to determine the strategic direction of the company. This involves:

• Understanding our core products and services, and scope of management system (see 4.2 below).

• Identifying “interested parties” (stakeholders) who receive our products and services, or who may be impacted by them, or those parties who may otherwise have a significant interest in our company. These parties are identified in the document Context of the Organization.

• Understanding internal and external issues that are of concern to Coldcurve Ltd and its interested parties; also identified in the document Context of the Organization. Many such issues are identified through an analysis of risks facing either Coldcurve Ltd or the interested parties. Such issues are monitored and updated as appropriate, and discussed as part of management reviews.

This information is then used by senior management to determine the company’s strategic direction. This is defined in records of management review, and periodically updated as conditions and situations change.

4.2 Scope of the Management System

4.2.1 Scope Statement

Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, Coldcurve Ltd has determined the scope of the management system as follows: Coldcurve Ltd located in Inverness-Shire, Scotland, producing bespoke automation systems within the UK. Services include panel design, panel build, SCADA, PLC & HMI programming and maintenance.

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4.2.2 Facilities With-in the Scope

The quality system applies to all processes, activities and employees within the company. The facility is located at:

The Old Moy Schoolhouse Inverness Moy IV13 7YE Phone: (01808) 511 765

Email: info@coldcurve.com Web: www.coldcurve.com

4.2.3 Permissible Exclusions

The company claims no exclusions from the ISO 9001 standard.

4.2.4 Scope of the Quality Management System Manual

This manual is prepared for the purpose of defining the company’s interpretations of the ISO 9001:2015 international standard, as well as to demonstrate how the company complies with that standard. This manual does not strictly follow the numbering structure of ISO 9001. Instead, Appendix B presents a cross reference between the sections of this manual and the clauses of ISO 9001:2015. This manual presents “Notes” which are used to define how Coldcurve Ltd has tailored its management system to suit its purposes. These are intended to clarify implementation approaches and interpretations for concepts which are not otherwise clearly defined in ISO 9001:2015. Notes appear in italics, with gray background. Where subordinate or supporting documentation is reference in this manual, these are indicated by bold italics.

5.0 Quality Policy

The Quality Policy of Coldcurve Ltd is as follows: Here at Coldcurve Ltd our activities are carried out in accordance with our quality management system which is working towards BS EN ISO 9001 certification. Our aims include:

▪ A quality service regardless of circumstances. ▪ To maintain excellent customer services and customer satisfaction. ▪ Customer expectations and requirements are understood and catered for. ▪ Work is carried out to an exacting standard consistently. ▪ Continual improvement through R&D and staff development. ▪ To always meet and exceed legislative requirements. ▪ Delivering our products and services on time and right the first time.

The Management Team will show leadership, commitment and bear the responsibility for establishing, implementing, integrating and maintaining the Quality Management System.

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Through direction and support, each employee will have a proper understanding of the importance of the Quality System functions, their responsibility to contribute to its effectiveness, and its direct relevance to the success of Coldcurve Ltd.

6.0 Management System Processes

6.1 Process Identification

Coldcurve Ltd has adopted a process approach for its management system. By identifying the top-level processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming products and services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the top-level processes. Note: not all activities are considered “processes” – the term “process” in this context indicates the activity has been elevated to a higher level of control and management oversight. The controls indicated herein are applicable only to the top-level processes identified. The following top-level processes have been identified for Coldcurve Ltd:

• Sales and Marketing

• Quoting and Orders

• Design and Development

• Production

Each process may be supported by other activities, such as tasks or sub-processes. Monitoring and control of top level processes ensures effective implementation and control of all subordinate tasks or sub-processes. Each top-level process has a Process Definition document which defines:

• applicable inputs and outputs

• process owner(s)

• applicable responsibilities and authorities

• applicable risks and opportunities

• critical and supporting resources

• criteria and methods employed to ensure the effectiveness of the process

The sequence of interaction of these processes is illustrated in Appendix A. Note: Appendix A represents the typical sequence of processes, and may be altered depending on customer or regulatory requirements at the job or contract level, as needed.

6.2 Process Controls & Objectives Each process has at least one objective established for it; this is a statement of the intent of the process. Each objective is then supported by at least one “metric” or key performance indicator (KPI)

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which is then measured to determine the process’ ability to meet the quality objective. Note: some processes have multiple objectives and multiple metrics. This is determined by the nature of the process, it’s impact on products and services, and associated risks. Note: Whereas ISO 9001 discusses process measurements and “quality objectives” as separate concepts, Coldcurve Ltd combines them; i.e., quality objectives are used to control the processes. Additional objectives for products and services may be assigned, but these will also be used to measure process effectiveness.

Throughout the year, metrics data is measured and gathered by process owners or other assigned managers, in order to present the data to Senior Management Team. The data is then analyzed by Senior Management Team in order that Senior Management Team may set goals and make adjustments for the purposes of long-term continual improvement. The specific quality objectives for each process are defined in the minutes of Management Review, per section 8.8. Metrics, along with current standings and goals for each objective, are recorded in records of management review. When a process does not meet a goal, or an unexpected problem is encountered with a process, the corrective and preventive action process is implemented to research and resolve the issue. In addition, opportunities for improvement are sought and implemented, for the identified processes.

6.3 Outsourced Processes

Any process performed by a third party is considered an “outsourced process” and must be controlled, as well. The company’s outsourced processes, and the control methods implemented for each, are defined in Outsourced Processes. The type and extent of control to be applied to the outsourced process take into consideration:

a) the potential impact of the outsourced process on the company’s capability to provide product that conforms to requirements,

b) the degree to which the control for the process is shared,

c) the capability of achieving the necessary control through the purchasing contract requirements.

7.0 Documentation & Records

7.1 General

The quality management system documentation includes both documents and records. Note: the ISO 9001:2015 standard uses the term “documented information”; Coldcurve Ltd does not use this term, but instead relies on the terms “document” and “record” to avoid confusion. In this context the terms are defined per section 3.0 above. Documents and records undergo different controls as defined herein.

The extent of the management system documentation has been developed based on the following: a) The size of Coldcurve Ltd

b) Complexity and interaction of the processes

c) Risks and opportunities

d) Competence of personnel

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7.2 Control of Documents

Documents required for the management system are controlled in accordance with procedure Control of Documents. The purpose of document control is to ensure that staff have access to the latest, approved information, and to restrict the use of obsolete information. All documented procedures are established, documented, implemented and maintained.

7.3 Control of Records

A documented procedure Control of Records has been established to define the controls needed for the identification, storage, retrieval, protection, retention time, and disposition of quality records. This procedure also defines the methods for controlling records that are created by and/or retained by suppliers. These controls are applicable to those records which provide evidence of conformance to requirements; this may be evidence of product and service requirements, contractual requirements, procedural requirements, or statutory/regulatory compliance. In addition, quality records include any records which provide evidence of the effective operation of the management system.

8.0 Management & Leadership

8.1 Management Leadership and Commitment

The Senior Management Team of Coldcurve Ltd provides evidence of its leadership and commitment to the development and implementation of the management system and continually improving its effectiveness by:

a) taking accountability of the effectiveness of the management system;

b) ensuring that the Quality Policy and quality objectives are established for the management system and are compatible with the strategic direction and the context of the organization;

c) ensuring that the quality policy is communicated, understood and applied within the organization;

d) ensuring the integration of the management system requirements into the organization’s other business processes, as deemed appropriate (see note);

e) promoting awareness of the process approach;

f) ensuring that the resources needed for the management system are available;

g) communicating the importance of effective quality management and of conforming to the management system requirements;

h) ensuring that the management system achieves its intended results;

i) engaging, directing and supporting persons to contribute to the effectiveness

of the management system;

j) promoting continual improvement;

k) supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility.

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Note: “business processes” such as accounting, employee benefits management and legal activities are out of scope of the QMS.

8.2 Customer Focus

The Senior Management Team of Coldcurve Ltd adopts a customer-first approach which ensures that customer needs and expectations are determined, converted into requirements and are met with the aim of enhancing customer satisfaction. This is accomplished by assuring:

a) customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b) the risks and opportunities that can affect conformity of product and service and the ability to enhance customer satisfaction are determined and addressed;

c) that the focus on enhancing customer satisfaction is maintained.

8.3 Quality Policy

Senior Management Team has developed the Quality Policy, defined in section 5.0 above, that governs day-to-day operations to ensure quality. The Quality Policy is released as a standalone document as well, and is communicated and implemented throughout the organization.

8.4 Organizational Roles Responsibilities & Authorities

The Senior Management Team has assigned responsibilities and authorities for all relevant roles in the company. These are communicated through the combination of the Organizational Chart and Position Descriptions. The Senior Management Team accepts responsibility and authority for:

a) ensuring that the management system conforms to applicable standards;

b) ensuring that the processes are delivering their intended outputs;

c) reporting on the performance of the management system;

d) providing opportunities for improvement for the management system;

e) ensuring the promotion of customer focus throughout the organization;

f) ensuring that the integrity of the management system is maintained when changes are

planned and implemented.

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8.5 Internal Communication

Senior Management Team of Coldcurve Ltd ensures internal communication takes place regarding the effectiveness of the management system. Internal communication methods include:

a) use of corrective and preventive action processes to report nonconformities or suggestions for improvement

b) use of the results of analysis of data

c) meetings (periodic, scheduled and/or unscheduled) to discuss aspects of the QMS

d) use of the results of the internal audit process

e) regular company meetings with all employees

f) internal emails

g) memos to employees

h) Coldcurve Ltd’s “open door” policy which allows any employee access to Senior Management Team for discussions on improving the quality system

8.6 Change Management

When Coldcurve Ltd determines the need for changes to the management system or its processes, these changes planned, implemented, and then verified for effectiveness; see the document Change Management. Documents are changed in accordance with procedure Control of Documents.

8.7 Risks and Opportunities

Note: Coldcurve Ltd deviates slightly from the approach towards risk and opportunity presented in ISO 9001. Instead, Coldcurve Ltd views “uncertainty” as neutral, but defines “risk” as a negative effect of uncertainty, and “opportunity” as a positive effect of uncertainty. Coldcurve Ltd has elected to manage risks and opportunities separately, except where they may overlap. Formal risk management may not be utilized in all instances; instead, the level of risk assessment, analysis, treatment and recordkeeping will be performed to the level deemed appropriate for each circumstance or application. Coldcurve Ltd considers risks and opportunities when taking actions within the management system, as well as when implementing or improving the management system; likewise, these are considered relative to products and services. Risks and opportunities are identified as part of the “Context of the Organization Exercise” defined in Context of the Organization, as well as throughout all other activities of the QMS. Risks and opportunities are managed in accordance with the document Risk and Opportunity Management. This procedure defines how risks are managed in order to minimize their likelihood and impact, and how opportunities are managed to improve their likelihood and benefit.

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8.8 Management Review

The Senior Management Team reviews the management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review includes assessing opportunities for improvement, and the need for changes to the management system, including the Quality Policy and quality objectives. Management review frequency, agenda (inputs), outputs, required members, actions taken and other review requirements are defined in the documented procedure Management Review. Records from management reviews are maintained.

9.0 Resources

9.1 Provision of Resources

Coldcurve Ltd determines and provides the resources needed: a) to implement and maintain the management system and continually improve its

effectiveness

b) to enhance customer satisfaction by meeting customer requirements

Resource allocation is done with consideration of the capability and constraints on existing internal resources, as well as needs related to supplier expectations. Resources and resource allocation are assessed during management reviews.

9.2 Human Resources

Senior management ensures that it provides sufficient staffing for the effective operation of the management system, as well its identified processes. Staff members performing work affecting product quality are competent on the basis of appropriate education, training, skills and experience. The documented procedure Hiring and Training defines these activities in detail. Training and subsequent communication ensure that staff are aware of:

a) the quality policy;

b) relevant quality objectives;

c) their contribution to the effectiveness of the management system, including the benefits of improved performance;

d) the implications of not conforming with the management system requirements.

Note: the management system does not include other aspects of Human Resources management, such as payroll, benefits, insurance, labour relations or disciplinary actions.

9.3 Infrastructure

Coldcurve Ltd determines, provides and maintains the infrastructure needed to achieve conformity

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to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated facilities;

b) process equipment, hardware and software;

c) supporting services such as transport;

d) information and communication technology.

Equipment is validated per the procedure Validation of Equipment and maintained per the procedure Preventive Maintenance. Where equipment is used for critical measurement activities, such as inspection and testing, these shall be subject to control and either calibration or verification; see the procedure Calibration of Equipment. Note: Calibration and measurement traceability is not employed for all measurement devices. Instead, Coldcurve Ltd determines which devices will be subject to calibration based on its processes, products and services, or in order to comply with specifications or requirements. These decisions are also based on the importance of a measurement, and considerations of risk.

9.4 Work Environment

Coldcurve Ltd provides a clean, safe and well-lit working environment. The Senior Management Team of Coldcurve Ltd manages the work environment needed to achieve conformity to product requirements. Specific environmental requirements for products are determined during quality planning and are documented in subordinate procedures, work instructions, or job documentation. Where special work environments have been implemented, these shall also be maintained per 9.3 above. Human factors are considered to the extent that they directly impact on the quality of products and services. Note: Social, psychological and safety aspects of the work environment are managed through activities outside of the scope of the management system. Only work environment aspects which can directly affect process efficiency or product and service quality are managed through the management system.

9.5 Organizational Knowledge

Coldcurve Ltd also determines the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This may include knowledge and information obtained from:

a) internal sources, such as lessons learned, feedback from subject matter experts, and/or intellectual property;

b) external sources such as standards, academia, conferences, and/or information gathered from customers or suppliers.

This knowledge shall be maintained, and made available to the extent necessary. When addressing changing needs and trends, Coldcurve Ltd shall consider its current knowledge and determine how to acquire or access the necessary additional knowledge.

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10.0 Operation

10.1 Operational Planning and Control

Coldcurve Ltd plans and develops the processes needed for product and service realization. Planning of product and service realization is consistent with the requirements of the other processes of the management system. Such planning considers the information related to the context of the organization (see section 4.0 above), current resources and capabilities, as well as product and service requirements. Changes to operational processes are done in accordance with the document Change Management.

10.2 Customer-Related Activities

During the intake of new business Coldcurve Ltd captures: a) requirements specified by the customer, including the requirements for delivery and post-

delivery activities;

b) requirements not stated by the customer but necessary for specified or intended use, where known

c) statutory and regulatory requirements related to the product and service;

d) any additional requirements determined by Coldcurve Ltd.

Once requirements are captured, Coldcurve Ltd reviews the requirements prior to its commitment to supply the product and service. This review ensures that:

a) product and service requirements are defined,

b) contract or order requirements differing from those previously expressed are resolved,

c) the organization has the ability to meet the defined requirements, and/or the claims for the products and services it offers, and

d) risks have been identified and considered.

These activities are defined in greater detail in the procedure Quoting and Order Acceptance.

10.3 Customer Communication

Coldcurve Ltd has implemented effective communication with customers in relation to:

a) providing information relating to products and services;

b) handling enquiries, contracts or orders, including changes;

c) obtaining customer feedback relating to products and services, including customer complaints;

d) handling or controlling customer property;

e) establishing specific requirements for contingency actions, when relevant.

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10.4 Design and Development

For new designs and for significant design changes, Coldcurve Ltd ensures the translation of customer needs and requirements into detailed design outputs. These address performance, reliability, maintainability, testability, and safety issues, as well as regulatory and statutory requirements. This process ensures:

a) Design planning is conducted

b) Design inputs (requirements) are captured

c) Design outputs are created under controlled conditions

d) Design reviews, verification and validation are conducted

e) Design changes are made in a controlled manner.

These activities are further defined in the document Design.

10.5 Purchasing

Coldcurve Ltd ensures that purchased products or services conform to specified purchase requirements. The type and extent of control applied to the supplier and the purchased products or services is dependent on the effect on subsequent product and service or the final product and service. Coldcurve Ltd evaluates and selects suppliers based on their ability to supply product and service in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation are established. Purchases are made via the release of formal purchase orders and/or contracts which clearly describe what is being purchased. Received products or services are then verified against requirements to ensure satisfaction of requirements. Suppliers who do not providing conforming products or services may be requested to conduct formal corrective actions. These activities are further defined in the documents Purchasing and Receiving.

10.6 Provision of products and services

10.6.1 Control of Provision of products and services

To control its provision of products and services, Coldcurve Ltd considers, as applicable, the following:

a) the availability of documents or records that define the characteristics of the products and services as well as the results to be achieved;

b) the availability and use of suitable monitoring and measuring resources;

c) the implementation of monitoring and measurement activities;

d) the use of suitable infrastructure and environment;

e) the appointment of competent persons, including any required qualifications;

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f) the implementation of actions to prevent human error;

g) the implementation of release, delivery and post-delivery activities.

At this time, Coldcurve Ltd does not utilize any in-house “special processes” where the result of the process cannot be verified by subsequent monitoring or measurement. Any such special processes are sent to outside suppliers, and controlled and an outsourced process per Outsourced Processes.

10.6.2 Identification and Traceability

Where appropriate, Coldcurve Ltd identifies its product and service or other critical process outputs by suitable means. Such identification includes the status of the product and service with respect to monitoring and measurement requirements. Unless otherwise indicated as nonconforming, pending inspection or disposition, or some other similar identifier, all product and service shall be considered conforming and suitable for use. If unique traceability is required by contract, regulatory, or other established requirement, Coldcurve Ltd controls and records the unique identification of the product and service.

The documented procedure Identification and Traceability defines these methods in detail.

10.6.3 Property Belonging to Third Parties

Coldcurve Ltd exercises care with customer or supplier property while it is under the organization’s control or being used by the organization. Upon receipt, such property is identified, verified, protected and safeguarded. If any such property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer or supplier and records maintained. For customer intellectual property, including customer furnished data used for design, production and / or inspection, this is identified by customer and maintained and preserved to prevent accidental loss, damage or inappropriate use. This activity is defined in greater detail in the document Control of Third-Party Property.

10.6.4 Preservation

Coldcurve Ltd preserves conformity of product or other process outputs during internal processing and delivery. This preservation includes identification, handling, packaging, storage, and protection. Preservation also applies to the constituent parts of a product. The documented procedure Preservation of Product defines the methods for preservation of product.

10.6.5 Post-Delivery Activities

As applicable, Coldcurve Ltd conducts the following activities which are considered “post-delivery activities”:

• Maintenance

• Document and record control

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• Process review

Post-delivery activities are conducted in compliance with the management system defined herein.

10.6.6 Process Change Control

Coldcurve Ltd reviews and controls both planned and unplanned changes to processes to the extent necessary to ensure continuing conformity with all requirements. Process change management is defined in the document Change Management.

10.6.7 Measurement and Release of products and services

Acceptance criteria for products and services are defined in appropriate subordinate documentation. Reviews, inspections and tests are conducted at appropriate stages to verify that the product and service requirements have been met. This is done before products and services are released or delivered. Each process utilizes different methods for measuring and releasing products and services. These methods are defined in Process Definitions.

10.6.8 Control of Nonconforming Outputs

Coldcurve Ltd ensures that products and services or other process outputs that do not conform to their requirements are identified and controlled to prevent their unintended use or delivery. The controls for such non-conformances are defined in Control of Nonconforming Product and Control of Nonconforming Service.

11.0 Improvement

11.1 General

Coldcurve Ltd uses the management system to improve its processes, products and services. Such improvements aim to address the needs and expectations of customers as well as other interested parties, to the extent possible. Improvement shall be driven by an analysis of data related to:

a) conformity of products and services;

b) the degree of customer satisfaction;

c) the performance and effectiveness of the management system;

d) the effectiveness of planning;

e) the effectiveness of actions taken to address risks and opportunities;

f) the performance of external providers;

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g) other improvements to the management system.

11.2 Customer Satisfaction

As one of the measurements of the performance of the management system, Coldcurve Ltd monitors information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information include:

• recording customer complaints

• product rejections or returns

• repeat orders for product

• changing volume of orders for product

• trends in on-time delivery

• obtain customer scorecards from certain customers

• submittal of customer satisfaction surveys

The corrective and preventive action system shall be used to develop and implement plans for customer satisfaction improvement that address deficiencies identified by these evaluations, and assess the effectiveness of the results.

11.3 Internal Audit

Coldcurve Ltd conducts internal audits at planned intervals to determine whether the management system conforms to contractual and regulatory requirements, to the requirements of ISO 9001, and to management system requirements. Audits also seek to ensure that the management system has been effectively implemented and is maintained. These activities are defined in the document Internal Audits.

11.4 Corrective and Preventive Action

Coldcurve Ltd takes corrective action to eliminate the cause of nonconformity in order to prevent recurrence. Likewise, the company takes preventive action to eliminate the causes of potential nonconformities in order to prevent their occurrence. These activities are done through the use of the formal Corrective Action (CAR) system, and are defined in the document Corrective and Preventive Action.

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Appendix A: Overall Process Sequence & Interaction

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Appendix B: ISO 9001:2015 Cross Reference

ISO 9001:2015 Clause Section in Manual

4.0 Context of the Organization (all)

4.1 Understanding the Organization & Its Context 4.1 Determining Our Strategic Direction

4.2 Understanding the needs & expectations of interested parties

4.1 Determining Our Strategic Direction

4.3 Determining the scope of the QMS 4.2 Scope of the Management System

4.4 Management system and its processes 6.0 Management System Processes

5.0 Leadership

5.1 Leadership & Commitment 8.1 Management Leadership and Commitment

5.1.1 General 8.1 Management Leadership and Commitment

5.1.2 Customer focus 8.2 Customer Focus

5.2 Policy 50 Quality Policy 8.3 Quality Policy

5.3 Organizational Roles Responsibilities and Authorities

5.4 Organizational Roles and Responsibilities and Authorities

6.0 Planning

6.1 Actions to address risks and opportunities 8.7 Risks and Opportunities

6.2 Quality objectives and planning to achieve them 6.2Process Controls & Objectives

6.3 Planning of changes 8.6 Change Management

7.0 Support

7.1 Resources

7.1.1 General 9.1 Provision of Resources

7.1.2 People 9.2 Human Resources

7.1.3 Infrastructure 9.3 Infrastructure

7.1.4 Environment for the operation of processes 9.4 Work Environment

7.1.5 Monitoring and measuring resources 9.3 Infrastructure

7.1.6 Organizational knowledge 9.5 Organizational Knowledge

7.2 Competence 9.2 Human Resources

7.3 Awareness 9.2 Human Resources

7.4 Communication 8.5 Internal Communication

7.5 Documented information 7.0 Documentation & Records

8.0 Operation

8.1 Operational planning and control 10.1 Operational Planning and Control

8.2 Requirements for products and services

8.2.1 Customer communication 10.3 Customer Communication

8.2.2 Determining the requirements related to products & services

10.2 Customer Related Activities

8.2.3 Review of requirements related to products & services

10.2 Customer Related Activities

8.2.4 Changes to requirements for products and services

10.2 Customer Related Activities

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ISO 9001:2015 Clause Section in Manual

8.3 Design and development of products and services 10.4 Design and Development

8.4 Control of externally provided processes, products & services

10.5 Purchasing

8.5 Production and service provision

8.5.1 Control of production and service provision 10.6.1 Control of Provision of products and services

8.5.2 Identification and traceability 10.6.2 Identification and Traceability

8.5.3 Property belonging to customers or external providers

10.6.3 Property Belonging to Third Parties

8.5.4 Preservation 10.6.4 Preservation

8.5.5 Post-delivery activities 10.6.5 Post-Delivery Activities

8.5.6 Control of changes 10.6.6 Process Change Control

8.6 Release of products and services 10.6.7 Measurement and Release of products and services

8.7 Control of nonconforming outputs 10.6.8 Control of Nonconforming Outputs

9.0 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.1.1 General 11.1 Improvement: General

9.1.2 Customer satisfaction 11.2 Customer Satisfaction

9.1.3 Analysis and evaluation 11.1 Improvement: General

9.2 Internal audit 11.3 Internal Audit

9.3 Management review 8.8 Management Review

10.0 Improvement

10.1 General 11.1 Improvement: General

10.2 Nonconformity and corrective action 11.4 Corrective and Preventive Action

10.3 Continual improvement 11.1 Improvement: General